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The WASH (Water or Saline at High Volumes) Trial: A Randomized Trial to Assess the Survival Impact of Extensive Peritoneal Lavage Using Distilled WAter or Saline at High Volumes After Pancreatic Resection for Pancreatic Ductal Adenocarcinoma (NCT02757859)

This randomized clinical trial studies how well high volume washing of the abdomen works in increasing survival after surgery in patients with pancreatic cancer that can be removed by surgery. High volume washings may remove free floating cancers present after surgery and help prolong survival in patients with pancreatic cancer.
  • Procedure: Pancreatectomy
    Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
    • Excision of the Pancreas
    • Pancreas Excision
  • Other: Lavage
    Receive extensive intraoperative peritoneal saline (EIPL-S) lavage
    • Irrigation
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)
  • A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively
  • In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
  • The subject is willing to consent to randomization of lavage vs. standard lavage
Exclusion Criteria:
  • The subject does not have a surgical indication for pancreatectomy
  • In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
  • The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard
  • Subject with neoadjuvant chemotherapy or chemoradiation
  • Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors
PRIMARY OBJECTIVES:

I. Overall survival (OS) (18 to 27 months after resection).

SECONDARY OBJECTIVES:

I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage.

OUTLINE: Patients are randomized to 1 of 3 arms.

Arm I (EIPL-S) extensive intraoperative peritoneal saline lavage: Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes.

Arm II (EIPL-D) extensive intraoperative peritoneal distilled water lavage: Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes.

Arm III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.

After completion of study treatment, patients are followed up every 3 months.

1 locations

United States (1)
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
    recruiting
    Philadelphia, Pennsylvania, United States, 19107
Status:
recruiting
Type:
Interventional
Phase:
-
Start:
26 April, 2016
Updated:
24 October, 2017
Participants:
667
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